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| Name | Class |
|---|---|
| Beijing Hospital | OTHER_GOV |
| Beijing Tongren Hospital | OTHER |
| Beijing Luhe Hospital | OTHER |
| Shanxi Province Renmin Hospital |
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This is a prospective multicenter single-arm phase II study, and the purpose of this study is to evaluate the efficiency of Orelabrutinib combined with PD-1 inhibitor regimen relapsed/refractory primary intraocular lymphoma. Overall response rate (ORR) after 4 cycles is the primary endpoint.
All the patients will be treated with Orelabrutinib combined with PD-1 inhibitor :Orelabrutinib 150mg qd,Tislelizumab Injection 200mg d1 or Sintilimab injection 200mg d1, every 21-day for 1 cycle). Patients will be evaluated every 2 cycles by MRI scan during the first 6 cycles,and then the interval of investigation will be prolonged to 12 weeks. The patients who achieved complete remission (CR) or partial remission (PR) or stable disease (SD) will receive further treatment. The patients progressed disease (PD) will withdraw from the trial and receive salvage regimens. The treatment will be continued for 2 years or until progression of the disease (PD), unacceptable toxicity, or patient/investigator discretion.
During following-up, surveillance ophthalmologic examination and brain magnetic resonance imaging (MRI) scans can be performed every 3 months up for 2 years.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| orelabrutinib combined with PD-1 inhibitor | Experimental | The experimental arm will be treated orelabrutinib plus PD-1(programmed death)inhibitor every 21 days as one cycle. The responses will be evaluated every 2 cycles during the first 6 cycles and every 3 months until progression. The investigators can choose Sintilimab Injection or Tislelizumab Injection at the beginning of treatment,but they can't exchange to another during the whole treatment. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| orelabrutinib | Drug | Orelabrutinib will be given as 150mg per day orally, until progression of the disease (PD), unacceptable toxicity, or patient/investigator discretion. |
|
| Measure | Description | Time Frame |
|---|---|---|
| overall response rate | ORR was calculated by the proportion of patients who achieved complete remission and partial remission. | 3 weeks after the end of 4 cycles of induction (each cycle is 21 days) |
| Measure | Description | Time Frame |
|---|---|---|
| 1 years progression-free survival | 1 years progression-free survival was calculated from the date of therapy until death from lymphoma or 1-year follow up without relapsing | from the date of treatment to the subject finished his 1 years follow-up phase or the disease relapsed or the death due to lymphoma |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wei Zhang | Recruiting | Beijing | Beijing Municipality | 100730 | China |
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| UNKNOWN |
| Henan Cancer Hospital | OTHER_GOV |
| Henan Province Renmin Hospital | UNKNOWN |
| The Second Affiliated Hospital of Dalian Medical University | OTHER |
| Hebei Medical University Fourth Hospital | OTHER |
| The First Hospital of Chinese Medical University | UNKNOWN |
| Qilu Hospital of Shandong University | OTHER |
| The First Affiliated Hospital of Zhengzhou University | OTHER |
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| Sintilimab | Drug | Sintilimab 200mg intravenous infusion d1, every 21 days for 1 cycle. The medicine will be given until progression of the disease (PD), unacceptable toxicity, or patient/investigator discretion. |
|
| Tislelizumab | Drug | Tislelizumab 200mg intravenous infusion d1, every 21 days for 1 cycle. The medicine will be given until progression of the disease (PD), unacceptable toxicity, or patient/investigator discretion. |
|
| ID | Term |
|---|---|
| C000729508 | orelabrutinib |
| C000632826 | sintilimab |
| C000707970 | tislelizumab |
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